Job Description
* Key Responsibilities

• Review executed batch records and executed protocols and meet the batch disposition timelines as per business requirement.
• Assist in review, release of materials, components used in planning and batch manufacturing.
• Prepare and summarize data associate with site metrics ,write, read, and revise technical reports
• Must have QA core experience , and have the ability to train and support staff regarding QA responsibilities as needed
• Conduct GMP investigations; specifically root cause analyses, risk assessments, and impact evaluations
• Adhere to all applicable regulations, policies, and procedure for health, safety and environmental compliance.
• Execute the assigned training and development plan.
• Troubleshoot systemic GMP issues
• Provide leadership on projects and within systems that interface with other departments
• Provides SME support, review and approval during meetings, audits, investigations, technical reports, etc.

* Key Interactions
INTERNAL STAKEHOLDERS NATURE/PURPOSE OF THE INTERACTION Manufacturing/Operations Inform team of necessary documentation corrections Quality Control Collaboration and problem solving during standard and non-routine events. Warehouse Relay information related to documentation needed for batch disposition.
EXTERNAL STAKEHOLDERS NATURE/PURPOSE OF THE INTERACTION Clients Occasional interaction with clients during visits or tours
* Physical Demands

• Ability to wear gowning materials for extended periods of time
• Required to maintain good personal hygiene
• Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected
• Periodic lifting up to 20 pounds
• Long periods of standing and walking

* Work Envoirnment

• This job primarily operates in a high demand office and manufacturing setting, periodically works inside the manufacturing core
• Potential limited exposure to hazardous chemicals
• Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PPS staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes.
• Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.

Qualifications
* Education Requirements

• Bachelor's Degree in physical or biological sciences or related scientific field preferred. High school diploma or equivalent required.

* Work Experience

• 3 years of QA experience performing quality related activities within a pharmaceutical manufacturing environment
• Must have previous experience working within QA Plant support (IPQA), strict regulatory guidelines, cGMP or FDA

* Functional or Technical Skills

• Thorough knowledge of cGMP and applicable FDA regulations
• Proficiency in the Microsoft Office applications (Word, Excel, Outlook and Access)
• Demonstrated ability to effectively communicate both verbally and in writing
• Ability to read and follow written instructions
• Detail oriented
• Understanding of sterile manufacturing preferred
• Technical writing skills preferred

About Us
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.

Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity

Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
About the Team
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited's investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.